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Pain Research & Management 2022Migraine is one of the most common types of headache, and it is the second most common cause of neurological disorders, with an annual prevalence of about 15% of the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Migraine is one of the most common types of headache, and it is the second most common cause of neurological disorders, with an annual prevalence of about 15% of the population. This study aimed to evaluate the effect of BoNT-A on the duration and intensity of migraine attacks. In addition, we investigated the effective injection sites.
METHODS
According to the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines, we searched online databases, including Web of Science, PubMed, EMBASE, Scopus, Cochrane Library, ProQuest, ClinicalTrials.gov, and Google Scholar from 2011 to 2021.
RESULTS
A total of 24 articles were included in the study. The use of BoNT-A in individuals suffering from chronic migraine (CM) decreases the frequency of migraine attacks per month, pain intensity, medication use, emergency visits, and migraine-related disabilities. The BoNT-A was well tolerated and leads to improved performance and better quality of life (QoL). Overall, treatment with BoNT-A in adults with CM is beneficial. In addition, the use of BoNT-A in individuals with vestibular migraine (VM) reduces the frequency of migraines and brings about the improvement of disability status caused by migraine headaches. Meanwhile, the use of BoNT-A reduces the frequency of migraine attacks per month among individuals with chronic refractory migraine (CRM).
CONCLUSIONS
The use of BoNT-A is a low-cost option for the treatment of various kinds of migraines, including chronic, episodic, unilateral, and vestibular types. BoNT-A can reduce the frequency of migraine attacks per month and diminish the severity of pain.
Topics: Adult; Botulinum Toxins, Type A; Headache; Humans; Migraine Disorders; Quality of Life; Treatment Outcome
PubMed: 35401888
DOI: 10.1155/2022/3284446 -
Medicina Oral, Patologia Oral Y Cirugia... Jul 2019Currently it has been shown that botulinum toxin is effective for a wide variety of medical conditions, and can be applied for therapeutic purposes as cosmetic. In...
BACKGROUND
Currently it has been shown that botulinum toxin is effective for a wide variety of medical conditions, and can be applied for therapeutic purposes as cosmetic. In recent years, there has been a growing trend in the use of this drug substance to control the muscular overactivity of bruxism. The objective of this study was the use of botulinum toxin type A (BTX-A) than traditional methods, by conducting a systematic review of randomized clinical trials (RCTs) published in the health sciences literature.
MATERIAL AND METHODS
An electronic search was made in the databases of the PubMed, Cochrane Library and Scopus data between March and October 2017, ECA, which will analyze the effect of botulinum toxin in the treatment of bruxism. We included studies of bruxist patients older than 18 years where BTX-A tests were performed on the masseter and / or temporal muscles and the control systems were injections of placebo (saline) or the use of traditional methods for the treatment of bruxism. such as occlusal splints, other medications or cognitive-behavioral therapy.
RESULTS
Of the 68 studies identified, 4 RCTs that fit our inclusion criteria were selected. These studies show that BTX-A injections can reduce the frequency of bruxism episodes, decrease pain levels and maximum occlusal force generated by this pathology, offer superior efficacy in the treatment of bruxism compared to control groups who were treated with placebo or with traditional methods for the treatment of bruxism.
CONCLUSION
Infiltrations with BTX-A are a safe and effective treatment for patients with bruxism, so its use is justified in daily clinical practice, especially in patients diagnosed with severe bruxism.
Topics: Botulinum Toxins, Type A; Bruxism; Humans; Injections, Intramuscular; Masseter Muscle; Neuromuscular Agents
PubMed: 31246937
DOI: 10.4317/medoral.22923 -
European Journal of Physical and... Aug 2022The complexity of spasticity requires a continuous effort in terms of more adapted treatments for patients, and accurate management. Through this systematic review, we...
INTRODUCTION
The complexity of spasticity requires a continuous effort in terms of more adapted treatments for patients, and accurate management. Through this systematic review, we aimed to evaluate and compare the effectiveness of extracorporeal shock wave therapy (ESWT) with botulinum toxin type A (BoNT-A) on reducing spasticity both in children and adults.
EVIDENCE ACQUISITION
An electronic search of PubMed/Medline, Scopus, Ovid Medline(R), and search engine of Google Scholar was performed. Publications ranging from January 2010 to January 2021, published in the English language and available as full-texts were eligible for inclusion and they were searched without any country restriction. The study was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) Guidelines.
EVIDENCE SYNTHESIS
A total of five studies were included in the present systematic review. Screening of the references, data extraction, and risk of bias assessment were performed by two independent authors. The methodological quality and risk of bias were conducted using the Physiotherapy Evidence Database (PEDro) Scale. The primary outcome was spasticity grade assessed by the Modified Ashworth Scale (MAS) and/or Modified Tardieu Scale (MTS). Additional outcomes were active range of motion (AROM), passive range of motion (PROM), upper extremity Fugl-Meyer Assessment (UE-FMA), pain intensity assessed through Visual Analogue Scale (VAS), spasm frequency scale (SFS), sonographic parameters, between-group comparison, and treatment response rate.
CONCLUSIONS
A beneficial effect on spasticity was found for both treatments: evidence showed that ESWT and BoNT-A can ameliorate spasticity considering parameters such as MAS, MTS, AROM, PROM, UE-FMA, VAS and SFS in post-stroke, multiple sclerosis, and cerebral palsy patients. Further research is required to strengthen the evidence, and more suitable study protocols are highly needed.
Topics: Adult; Botulinum Toxins, Type A; Child; Extracorporeal Shockwave Therapy; Humans; Muscle Spasticity; Stroke; Stroke Rehabilitation; Treatment Outcome
PubMed: 35412036
DOI: 10.23736/S1973-9087.22.07136-2 -
Toxins Nov 2022Physiotherapy is mentioned as an adjunctive treatment to improve the symptoms of cervical dystonia in terms of pain, function and quality of life. However, botulinum... (Review)
Review
Physiotherapy is mentioned as an adjunctive treatment to improve the symptoms of cervical dystonia in terms of pain, function and quality of life. However, botulinum neurotoxin injection remains the treatment of choice. This systematic review emphasizes physical therapy and evaluates it by including six studies. The methodology is based on a previous systematic review on this topic to provide better comparability and actuality. For this purpose, two databases were searched using the previously published keywords. This time, only randomised controlled trials were evaluated to increase the power. In conclusion, additional physical therapy and active home exercise programs appear to be useful. Further research should focus on the dose-response principle to emphasize physical therapy treatment modalities.
Topics: Humans; Torticollis; Quality of Life; Physical Therapy Modalities; Botulinum Toxins; Exercise Therapy
PubMed: 36422957
DOI: 10.3390/toxins14110784 -
Hernia : the Journal of Hernias and... Dec 2021To systematically review technical aspects and treatment regimens of botulinum toxin A (BTA) injections in the lateral abdominal wall musculature. We also investigated... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
To systematically review technical aspects and treatment regimens of botulinum toxin A (BTA) injections in the lateral abdominal wall musculature. We also investigated the effect of BTA on abdominal muscle- and hernia dimensions, and clinical outcome.
METHODS
PubMed, EMBASE, CENTRAL, and CINAHL were searched for studies that investigate the injection of BTA in the lateral abdominal wall muscles. Study characteristics, BTA treatment regimens, surgical procedures, and clinical outcomes are presented descriptively. The effect of BTA on muscle- and hernia dimensions is analyzed using random-effects meta-analyses, and exclusively for studies that investigate ventral incisional hernia patients.
RESULTS
We identified 23 studies, comprising 995 patients. Generally, either 500 units of Dysport or 200-300 units of Botox are injected at 3-5 locations bilaterally in all three muscles of the lateral abdominal wall, about 4 weeks prior to surgery. No major procedural complications are reported. Meta-analyses show that BTA provides significant elongation of the lateral abdominal wall of 3.2 cm per side (95% CI 2.0-4.3, I = 0%, p < 0.001); 6.3 cm total elongation, and a significant but heterogeneous decrease in transverse hernia width (95% CI 0.2-6.8, I = 94%, p = 0.04). Furthermore, meta-analysis shows that BTA pretreatment in ventral hernia patients significantly increases the fascial closure rate [RR 1.08 (95% CI 1.02-1.16, I = 0%, p = 0.02)].
CONCLUSION
The injection technique and treatment regimens of botulinum toxin A as well as patient selection require standardization. Bilateral pretreatment in hernia patients significantly elongates the lateral abdominal wall muscles, making fascial closure during surgical hernia repair more likely.
STUDY REGISTRATION
A review protocol for this meta-analysis was registered at PROSPERO (CRD42020198246).
Topics: Abdominal Muscles; Abdominal Wall; Botulinum Toxins, Type A; Hernia, Ventral; Herniorrhaphy; Humans; Neuromuscular Agents; Preoperative Care; Surgical Mesh
PubMed: 34546475
DOI: 10.1007/s10029-021-02499-1 -
The Cochrane Database of Systematic... Jul 2021Botulinum toxin type A (BontA) is the most frequent treatment for facial wrinkles, but its effectiveness and safety have not previously been assessed in a Cochrane... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Botulinum toxin type A (BontA) is the most frequent treatment for facial wrinkles, but its effectiveness and safety have not previously been assessed in a Cochrane Review.
OBJECTIVES
To assess the effects of all commercially available botulinum toxin type A products for the treatment of any type of facial wrinkles.
SEARCH METHODS
We searched the following databases up to May 2020: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched five trials registers, and checked the reference lists of included studies for further references to relevant randomised controlled trials (RCTs).
SELECTION CRITERIA
We included RCTs with over 50 participants, comparing BontA versus placebo, other types of BontA, or fillers (hyaluronic acid), for treating facial wrinkles in adults.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. Primary outcomes were participant assessment of success and major adverse events (AEs) (eyelid ptosis, eyelid sensory disorder, strabismus). Secondary outcomes included physician assessment of success; proportion of participants with at least one AE and duration of treatment effect. We used GRADE to assess the certainty of the evidence for each outcome.
MAIN RESULTS
We included 65 RCTs, involving 14,919 randomised participants. Most participants were female, aged 18 to 65 years. All participants were outpatients (private office or day clinic). Study duration was between one week and one year. No studies were assessed as low risk of bias in all domains; the overall risk of bias was unclear for most studies. The most common comparator was placebo (36 studies). An active control was used in 19 studies. There were eight dose-ranging studies of onabotulinumtoxinA, and a small number of studies compared against fillers. Treatment was given in one cycle (54 studies), two cycles (three studies), or three or more cycles (eight studies). The treated regions were glabella (43 studies), crow's feet (seven studies), forehead (two studies), perioral (two studies), full face (one study), or more than two regions (nine studies). Most studies analysed moderate to severe wrinkles; mean duration of treatment was 20 weeks. The following results summarise the main comparisons, based on studies of one treatment cycle for the glabella. AEs were collected over the duration of these studies (over four to 24 weeks). Compared to placebo, onabotulinumtoxinA-20 U probably has a higher success rate when assessed by participants (risk ratio (RR) 19.45, 95% confidence interval (CI) 8.60 to 43.99; 575 participants; 4 studies; moderate-certainty evidence) or physicians (RR 17.10, 95% CI 10.07 to 29.05; 1339 participants; 7 studies; moderate-certainty evidence) at week four. Major AEs are probably higher with onabotulinumtoxinA-20 U (Peto OR 3.62, 95% CI 1.50 to 8.74; 1390 participants; 8 studies; moderate-certainty evidence), but there may be no difference in any AEs (RR 1.14, 95% CI 0.89 to 1.45; 1388 participants; 8 studies; low-certainty evidence). Compared to placebo, abobotulinumtoxinA-50 U has a higher participant-assessed success rate at week four (RR 21.22, 95% CI 7.40 to 60.56; 915 participants; 6 studies; high-certainty evidence); and probably has a higher physician-assessed success rate (RR 14.93, 95% CI 8.09 to 27.55; 1059 participants; 7 studies; moderate-certainty evidence). There are probably more major AEs with abobotulinumtoxinA-50 U (Peto OR 3.36, 95% CI 0.88 to 12.87; 1294 participants; 7 studies; moderate-certainty evidence). Any AE may be more common with abobotulinumtoxinA-50 U (RR 1.25, 95% CI 1.05 to 1.49; 1471 participants; 8 studies; low-certainty evidence). Compared to placebo, incobotulinumtoxinA-20 U probably has a higher participant-assessed success rate at week four (RR 66.57, 95% CI 13.50 to 328.28; 547 participants; 2 studies; moderate-certainty evidence), and physician-assessed success rate (RR 134.62, 95% CI 19.05 to 951.45; 547 participants; 2 studies; moderate-certainty evidence). Major AEs were not observed (547 participants; 2 studies; moderate-certainty evidence). There may be no difference between groups in any AEs (RR 1.17, 95% CI 0.90 to 1.53; 547 participants; 2 studies; low-certainty evidence). AbobotulinumtoxinA-50 U is no different to onabotulinumtoxinA-20 U in participant-assessed success rate (RR 1.00, 95% CI 0.92 to 1.08, 388 participants, 1 study, high-certainty evidence) and physician-assessed success rate (RR 1.01, 95% CI 0.95 to 1.06; 388 participants; 1 study; high-certainty evidence) at week four. Major AEs are probably more likely in the abobotulinumtoxinA-50 U group than the onabotulinumtoxinA-20 U group (Peto OR 2.65, 95% CI 0.77 to 9.09; 433 participants; 1 study; moderate-certainty evidence). There is probably no difference in any AE (RR 1.02, 95% CI 0.67 to 1.54; 492 participants; 2 studies; moderate-certainty evidence). IncobotulinumtoxinA-24 U may be no different to onabotulinumtoxinA-24 U in physician-assessed success rate at week four (RR 1.01, 95% CI 0.96 to 1.05; 381 participants; 1 study; low-certainty evidence) (participant assessment was not measured). One participant reported ptosis with onabotulinumtoxinA, but we are uncertain of the risk of AEs (Peto OR 0.02, 95% CI 0.00 to 1.77; 381 participants; 1 study; very low-certainty evidence). Compared to placebo, daxibotulinumtoxinA-40 U probably has a higher participant-assessed success rate (RR 21.10, 95% CI 11.31 to 39.34; 683 participants; 2 studies; moderate-certainty evidence) and physician-assessed success rate (RR 23.40, 95% CI 12.56 to 43.61; 683 participants; 2 studies; moderate-certainty evidence) at week four. Major AEs were not observed (716 participants; 2 studies; moderate-certainty evidence). There may be an increase in any AE with daxibotulinumtoxinA compared to placebo (RR 2.23, 95% CI 1.46 to 3.40; 716 participants; 2 studies; moderate-certainty evidence). Major AEs reported were mainly ptosis; BontA is also known to carry a risk of strabismus or eyelid sensory disorders.
AUTHORS' CONCLUSIONS
BontA treatment reduces wrinkles within four weeks of treatment, but probably increases risk of ptosis. We found several heterogeneous studies (different types or doses of BontA, number of cycles, and different facial regions) hindering meta-analyses. The certainty of the evidence for effectiveness outcomes was high, low or moderate; for AEs, very low to moderate. Future RCTs should compare the most common BontA (onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, daxibotulinumtoxinA, prabotulinumtoxinA) and evaluate long-term outcomes. There is a lack of evidence about the effects of multiple cycles of BontA, frequency of major AEs, duration of effect, efficacy of recently-approved BontA and comparisons with other treatments.
Topics: Adult; Aged; Bias; Botulinum Toxins, Type A; Dermal Fillers; Face; Female; Humans; Male; Middle Aged; Placebos; Randomized Controlled Trials as Topic; Skin Aging
PubMed: 34224576
DOI: 10.1002/14651858.CD011301.pub2 -
Aesthetic Surgery Journal Apr 2022Botulinum toxin A (BoNT-A) injections are a popular non-surgical procedure for facial rejuvenation. Its increase in popularity and utilization is met with limited... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Botulinum toxin A (BoNT-A) injections are a popular non-surgical procedure for facial rejuvenation. Its increase in popularity and utilization is met with limited regulations, potentially posing a significant risk to patient safety and public health.
OBJECTIVES
The authors sought to assess the safety profile of cosmetic glabellar and forehead BoNT-A injections and evaluate BoNT-A type on complication rate.
METHODS
A systematic search of MEDLINE and EMBASE was performed for studies reporting complications after cosmetic BoNT-A in the glabellar or in the forehead region in the glabellar or in the forehead region. A random effects meta-analysis was carried out to assess complication rate. Where there were sufficient randomized-controlled trials, a network meta-analysis was performed.
RESULTS
Of 556 identified articles, 24 were included in the final quantitative analysis, with 4268 BoNT-A injection sessions and 1234 placebos. Frequently observed treatment-related complications in the BoNT-A intervention group included headache, local skin reactions, and facial neuromuscular symptoms. The overall BoNT-A complication rate was 16%. The odds ratio of developing complications from abobotulinum toxin injections compared with placebo was 1.62 (1.15, 2.27; P > 0.05) and that from onabotulinum toxin injections compared with placebo was 1.34 (0.52, 3.48; P > 0.05). In 30% of the studies, the injectors were doctors, whereas the training status of the practitioner was not reported in the remaining 70%.
CONCLUSIONS
Cosmetic BoNT-A injections in the glabellar and forehead region appear to be safe, and most complications are mild and transient. Nevertheless, the literature demonstrates heterogeneous reporting of complications and a lack of consistency of the definition of treatment-related complications.
Topics: Botulinum Toxins, Type A; Face; Forehead; Humans; Neuromuscular Agents; Skin Aging
PubMed: 35178552
DOI: 10.1093/asj/sjac036 -
Stomatologija 2021The aim of the systematic review was to analyze the effectiveness of Botox injections for the treatment of the gummy smile.
PURPOSE
The aim of the systematic review was to analyze the effectiveness of Botox injections for the treatment of the gummy smile.
MATERIALS AND METHODS
The systematic literature search was done in the databases: PubMed, Embase and Cochrane Library. The articles published from 2013 to 2020 were searched. Only studies on humans were included in this systematic literature review.
RESULTS
During the initial search a total number of 139 articles were detected. However, after the removal of duplications 105 articles were left. Regarding the application of inclusion and exclusion criteria, 6 articles were selected for this systematic literature review.
CONCLUSIONS
The results of this study suggested that botulinum toxin was an efficient method to treat the gummy smile.
Topics: Botulinum Toxins, Type A; Esthetics, Dental; Gingiva; Humans; Injections, Intramuscular; Smiling
PubMed: 35319495
DOI: No ID Found -
Cephalalgia : An International Journal... Apr 2023This systematic review focuses on chronic migraine patients with medication overuse headache using, respectively, topiramate, botulinum toxin type A, and human... (Meta-Analysis)
Meta-Analysis Review
Randomized controlled studies evaluating Topiramate, Botulinum toxin type A, and mABs targeting CGRP in patients with chronic migraine and medication overuse headache: A systematic review and meta-analysis.
BACKGROUND
This systematic review focuses on chronic migraine patients with medication overuse headache using, respectively, topiramate, botulinum toxin type A, and human monoclonal antibodies targeting calcitonin gene-related peptide or its receptor.
METHODS
A systematic search was conducted in the databases CENTRAL, MEDLINE, Embase and Web of Science until May 2022. We included randomized controlled trials reporting the outcomes of change in monthly headache/migraine days, ≥50% response rates and change in medication overuse status. Studies were excluded if response rates were not reported. Risk of bias assessment was performed using the Cochrane RoB2 tool. The quality of evidence for outcomes across included studies was evaluated according to the five factors outlined in Cochrane GRADE approach.
FINDINGS
The initial search resulted in 1599 records. Following screening, 10 studies met our inclusion criteria, while seven studies with sufficient data were included in the meta-analysis. Studies assessing Botulinum toxin type A included 1139 patients and showed a mean reduction in headache frequency by 1.92 days per month compared to placebo (-1.92; 95% CI -2.68 to -1.16). Studies assessing human monoclonal antibodies included 1982 patients, and showed significant positive effect compared to placebo for all measured outcomes. The overall odds ratio for the ≥50% response rate was 2.90 (95% CI, 2.23 to 3.78). No significant difference was observed in the frequency of adverse effect for both Botulinum toxin type A and low dose of human monoclonal antibodies compared to placebo. There is currently insufficient evidence to determine the impact of topiramate in chronic migraine patients with medication overuse headache.
INTERPRETATION
Botulinum toxin type A and human monoclonal antibodies targeting calcitonin gene-related peptide receptor were beneficial in reducing monthly migraine days and ≥50% response rate, but uncertainties remained for Botulinum toxin type A regarding response rate. The effect size for human monoclonal antibodies was greater with relatively lower drop-out rate. High-quality randomized trials are required to evaluate the effect of topiramate in chronic migraine patients with medication overuse headache.
Topics: Humans; Topiramate; Botulinum Toxins, Type A; Calcitonin Gene-Related Peptide; Migraine Disorders; Headache; Headache Disorders, Secondary; Antibodies, Monoclonal
PubMed: 36856015
DOI: 10.1177/03331024231156922 -
The Cochrane Database of Systematic... May 2020Congenital talipes equinovarus (CTEV), also known as clubfoot, is a common congenital orthopaedic condition characterised by an excessively turned-in foot (equinovarus)...
BACKGROUND
Congenital talipes equinovarus (CTEV), also known as clubfoot, is a common congenital orthopaedic condition characterised by an excessively turned-in foot (equinovarus) and high medial longitudinal arch (cavus). If left untreated it can result in long-term disability, deformity and pain. Interventions can be conservative (such as splinting or stretching) or surgical. Different treatments might be effective at different stages: at birth (initial presentation); when initial treatment does not work (resistant presentation); when the initial treatment works but the clubfoot returns (relapse/recurrent presentation); and when there has been no early treatment (neglected presentation). This is an update of a review first published in 2010 and last updated in 2014.
OBJECTIVES
To assess the effects of any intervention for any type of CTEV in people of any age.
SEARCH METHODS
On 28 May 2019, we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL Plus, AMED and Physiotherapy Evidence Database. We also searched for ongoing trials in the WHO International Clinical Trials Registry Platform and ClinicalTrials.gov (to May 2019). We checked the references of included studies.
SELECTION CRITERIA
Randomised controlled trials (RCTs) and quasi-RCTs evaluating interventions for CTEV, including interventions compared to other interventions, sham intervention or no intervention. Participants were people of all ages with CTEV of either one or both feet.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed the risks of bias in included trials and extracted the data. We contacted authors of included trials for missing information. We collected adverse event information from trials when it was available. When required we attempted to obtain individual patient data (IPD) from trial authors for re-analysis. If unit-of-analysis issues were present and IPD unavailable we did not report summary data, MAIN RESULTS: We identified 21 trials with 905 participants; seven trials were newly included for this update. Fourteen trials assessed initial cases of CTEV (560 participants), four trials assessed resistant cases (181 participants) and three trials assessed cases of unknown timing (153 participants). The use of different outcome measures prevented pooling of data for meta-analysis, even when interventions and participants were comparable. All trials displayed high or unclear risks of bias in three or more domains. Twenty trials provided data. Two trials reported on the primary outcome of function using a validated scale, but the data were not suitable for inclusion because of unit-of-analysis issues, as raw data were not available for re-analysis. We were able to analyse data on foot alignment (Pirani score), a secondary outcome, from three trials in participants at initial presentation. The Pirani score is a scale ranging from zero to six, where a higher score indicates a more severe foot. At initial presentation, one trial reported that the Ponseti technique significantly improved foot alignment compared to the Kite technique. After 10 weeks of serial casting, the average total Pirani score of the Ponseti group was 1.15 points lower than that of the Kite group (mean difference (MD) -1.15, 95% confidence interval (CI) -1.32 to -0.98; 60 feet; low-certainty evidence). A second trial found the Ponseti technique to be superior to a traditional technique, with mean total Pirani scores of the Ponseti participants 1.50 points lower than after serial casting and Achilles tenotomy (MD -1.50, 95% CI -2.28 to -0.72; 28 participants; very low-certainty evidence). One trial found evidence that there may be no difference between casting materials in the Ponseti technique, with semi-rigid fibreglass producing average total Pirani scores 0.46 points higher than plaster of Paris at the end of serial casting (95% CI -0.07 to 0.99; 30 participants; low-certainty evidence). We found no trials in relapsed or neglected cases of CTEV. A trial in which the type of presentation was not reported showed no evidence of a difference between an accelerated Ponseti and a standard Ponseti treatment in foot alignment. At the end of serial casting, the average total Pirani score in the accelerated group was 0.31 points higher than the standard group (95% CI -0.40 to 1.02; 40 participants; low-certainty evidence). No trial assessed gait using a validated assessment. Health-related quality of life was reported in some trials but data were not available for re-analysis. There is a lack of evidence for the addition of botulinum toxin A during the Ponseti technique, different types of major foot surgery or continuous passive motion treatment following major foot surgery. Most trials did not report on adverse events. Two trials found that further serial casting was more likely to correct relapse after Ponseti treatment than after the Kite technique, which more often required major surgery (risk differences 25% and 50%). In trials evaluating serial casting techniques, adverse events included cast slippage (needing replacement), plaster sores (pressure areas), and skin irritation. Adverse events following surgical procedures included infection and the need for skin grafting.
AUTHORS' CONCLUSIONS
From the evidence available, the Ponseti technique may produce significantly better short-term foot alignment compared to the Kite technique. The certainty of evidence is too low for us to draw conclusions about the Ponseti technique compared to a traditional technique. An accelerated Ponseti technique may be as effective as a standard technique, but results are based on a single small comparative trial. When using the Ponseti technique semi-rigid fibreglass casting may be as effective as plaster of Paris. Relapse following the Kite technique more often led to major surgery compared to relapse following the Ponseti technique. We could draw no conclusions from other included trials because of the limited use of validated outcome measures and the unavailability of raw data. Future RCTs should address these issues.
Topics: Botulinum Toxins, Type A; Casts, Surgical; Clubfoot; Decompression, Surgical; Female; Humans; Infant; Infant, Newborn; Ligaments, Articular; Male; Motion Therapy, Continuous Passive; Neuromuscular Agents; Orthopedic Procedures; Randomized Controlled Trials as Topic; Recurrence; Treatment Outcome
PubMed: 32412098
DOI: 10.1002/14651858.CD008602.pub4